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Nearly six years ago, in 2015, the FDA attempted to slip a change to its “intended use” regulations (21 C.F.R. §§201.128, 801.4) – which had not been updated since the 1950s – through the administrative process by hiding it in a Federal Register notice about electronic cigarettes.  80 Fed. Reg. 57756 (FDA Sept. 25, 2015). 

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With apologies, this time, to Sir Paul − “The circuit judge, who held a grudge, has put the FDA’s banned on the run. . . .”

That’s just about what happened in Judge Rotenberg Educational Center, Inc. v. United States FDA, ___ F.4th ___, 2021 WL 2799891 (D.C. Cir. July 6, 2021) (note the

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The United States Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), determined that “off-label usage” is “accepted and necessary” by both the FDA and the medical community.  Id. at 350.  Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.”  Id. at 351 n.5 (citation and quotation marks omitted). 

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Back in 1998, Bexis published the first major law review article about off-label use of drugs and medical devices and tort liability, James Beck & Elizabeth Azari, “FDA, Off-Label Use, & Informed Consent:  Debunking Myths & Misconceptions,” 53 Food & Drug L.J. 71 (1998).  This article came to be cited twice by the United States

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A long time ago in a law school relatively far away, we took torts as a first year law student.  Many of the cases about which we learned (or were supposed to have learned) were from even longer ago and we had no idea how much some of those old cases would inform our practice. 

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It’s a unique relationship based largely on knowledge and trust.  Doctor’s not only have to rely on their medical knowledge, but they need to apply that to their knowledge of the patient.  Knowledge that often develops overtime through trust.  Patients want and need to be able to trust their doctors.  Sometimes patients share information with